NCT07452952

Relationship Between the Level of Positive End-expiratory Pressure and Venous Congestion During Acute Respiratory Distress Syndrome.

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: University Hospital, Angers · Other Government
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The main objective is to assess the effect of increased PEEP on echo-Doppler venous congestion in ARDS patients at two PEEP levels, by grading congestion in each venous flow (suprahepatic, renal, portal) as "absent," "moderate," or "severe," and also calculating the VExUS score.

Detailed description

All analyzes will be carried out with collection intention. All information required by the protocol is obtained from the clinical file of the Intensive care and Hyperbaric Medicine department of Angers University Hospital. This research is not involving humans on prospective data from care. This research does not require any specific investigation and does not involve no changes to support. Clinical and biological data to be collected at inclusion (D1) : * Demographic data: age, sex, weight (on the day of admission to intensive care and day of inclusion), medical history. * Cause of ARDS. * Ventilatory parameters: PEEP set by the clinician, total PEEP, Pplat, tidal volume, inspiratory and expiratory esophageal pressure if available as part of the treatment. * Hemodynamic parameters: systolic, diastolic, mean aretrial blood pressure ; central venous pressure (if available as part of routine care); heart rate; transpulmonary thermodilution monitor data (if available as part of the routine care) or Swan-ganz catheter (if available as part of the routine care), vasoactive treatments (type and dosage). Assessments to be carried out as part of routine care on D1, between D3 and D5 and between D6 and D8 : 1. Measures relating to the mechanics of the respiratory system: * Measurement of airway opening pressure (AOP). * Calculation of the R/I ratio (recruitability index) * The two PEEP levels, high and low, chosen by the clinician for performing the following measurements. 2. At the two PEEP levels, the investigator will retrospectively collect the following clinical, biological, and echographic measurements, which were prospectively recorded by the clinician. * Cardiac ultrasound: * Right ventricular function parameters (TAPSE, S' wave, Vmax IT, diameter VD). * Cardiac output. * LVEF (once only) * Evaluation of venous congestion by Doppler of the veins : * Venous congestion is initially assessed by studying each flow individually. Doppler (suprahepatic veins, renal interlobar veins and portal vein) and graded in "absent", "moderate" or "severe" as follows : * Suprahepatic veins: S wave \> D = absent (normal) ; S wave \< D = moderate ; Positive S wave = severe * Renal interlobar veins: Continuous flow = absent (normal) ; Biphasic flow = moderate ; Monophasic flow = severe * Portal vein: Pulsatility index \< 30% = absent (normal) ; Pulsatility index ≥ 30% and ≤ 50% = moderate ; Pulsatility index \> 50% = severe NB : calculation of the portal trunk pulsatility index (\[(Vmax - Vmin) / Vmax\], average of 3 measurements) Then the VExUS score, integrating these three signals as well as the study of the diameter of the inferior vena cavan by ultrasound, is calculated as follows: * Grade 0 "absence of congestion": VCi \< 20mm; * Grade 1 "mild congestion": VCi ≥ 20 mm and suprahepatic venous Doppler, portal and renal normal or with signs of moderate congestion; * Grade 2 "moderate congestion": VCi ≥ 20 mm and presence one venous flow (suprahepatic, portal, or renal) showing evidence of severe congestion; * Grade 3 "severe congestion": VCi ≥ 20 mm and presence of several flows vein showing signs of severe congestion. * Arterial and central venous gasometry (ScVO 2, PaCO2, PvCO2, lactate, PaO2, pH). * Collection of hemodynamic parameters: systolic blood pressure, mean, diastolic, heart rate, central venous pressure. * In patients with a pulmonary artery catheter: data collection following: systolic, diastolic and average PAP, cardiac index * Collection of ventilatory parameters: plateau pressure, total PEEP, and, if available, end-inspiratory and end-expiratory esophageal pressures. 3. Collection of renal function with: * Serum creatinine and urea * Creatininuria on urine ionogram * 24-hour diuresis 4. Collection of weight and input-output balance 5. The echocardiographic data collected at inclusion and during follow-up will be processed a posteriori by two different observers. End of monitoring data (D28): During this visit, the following elements will be collected: * Occurrence of acute renal failure (according to KDIGO criteria) on day 8. * Use or not of extra-renal purification * Survival at D28 (to characterize the population)

Conditions

• Mechanical Ventilation
• Acute Respiratory Distress Syndrome (ARDS)

Interventions

Type	Name	Description
OTHER	Non-interventionnal study	Non-interventionnal study

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2026-03-05
• Last updated: 2026-03-05

Locations

1 site across 1 country: France